Apparatus and methods for pain relief using ultrasound waves in combination with cryogenic energy

ABSTRACT

The method and device of the present invention for pain relief using ultrasound waves in combination with cryogenic energy includes a generator and a transducer to produce ultrasonic waves and a cryogenic source to produce cryogenic energy. Ultrasound waves are delivered to the target in combination with cryogenic energy. Ultrasound waves and cryogenic energy can be delivered to the target from the radial side of the ultrasound horn and/or tip or can be delivered from the distal end of the ultrasound tip. Cryogenic energy can also be delivered directly to the target through a central orifice. Ultrasound energy can also be delivered through a cryogenic spray at the distal end. The use of ultrasound waves in combination with cryogenic energy can provide an analgesic effect.

BACKGROUND OF THE INVENTION

1. Field of the Invention

The present invention relates to pain relief. In particular, the presentinvention relates to apparatus and methods for pain relief usingultrasound waves in combination with cryogenic energy.

2. Description of the Related Art

The use of ultrasound as a source of heat to treat pain is well known inthe art. Heat generated by ultrasound is utilized to treat pain byeither ablating the nociceptive nerve and nerve endings responding tothe pain (for example U.S. Pat. No. 5,433,739 to Sluijter et al and U.S.Pat. No. 6,073,051 to Sharkey et al) or by warming the target tissue(for example Patent No. 50460,595 to Hall et al and U.S. Pat. No.5,413,550 to Castel). The former method treats pain by permanentlyremoving the body's ability to sense pain in the treated area. It hasbeen suggested that damage to tissue surrounding the target tissue to beablated by ultrasonic energy can be reduced by cooling the ultrasoundelectrode (U.S. Pat. No. 5,186,181 to Franconi et al). While removingthe ability to sense to pain may provide short-term therapeuticbenefits, it can cause long term harm by preventing the patient fromdetecting the development of new pathologies or the worsening ofexisting pathologies in the treated area. Unable to sense the painassociated with pathologic changes, the patient will delay seekingtreatment thereby lowering the patient's prognosis.

Treating pain by heating the target the tissue with ultrasonic energyhas been proven effective. Assuming the therapeutic effects ofultrasound administration are tied to a thermal effect, these methodsattempt to raise the temperature of the target tissue anywhere from 1 to4 degree Celsius; deep pain and chronic pain are treated with highertemperatures (U.S. Pat. No. 5,413,550 to Castel). Heating target tissue,however, runs the risk of burning the patient or otherwise producingpatient discomfort. Furthermore, studies investigating the therapeuticeffects of ultrasound suggest that analgesic effects are not dependentupon the thermal effects of ultrasound. (Hsieh. Effects of ultrasoundand diclofenac phonophoresis on inflammatory pain relief: suppression ofinducible nitric oxide synthase in arthritic rats. Physical Therapy2006; 86: 39-49; Young and Dyson. Effect of therapeutic ultrasound onthe healing of full-thickness excised skin lesions. Ultrasonics 1990;28: 175-180; Dino et al. The significance of membrane changes in thesafe and effective use of therapeutic arid diagnostic ultrasound.Physics in Medicine and Biology 1989; 34: 1543-1552.) Thus the use ofultrasound as an analgesic heat source is misguided and exposes thepatient to unnecessary risks.

The use of cold temperatures to provide pain relief is also well-known.The most frequent use is the standard ice-pack that is used in everydayhomes. The analgesic effect cool temperature provides stems from thecooling of neuronal tissue that causes the neuronal tissue to ceasefunctioning. The use of cold temperatures for pain relief has evolvedinto a different format: cryogenics are now used to cool or freezeneuronal tissue such as nerves to produce an analgesic effect. Thefreezing of the tissue, however, provides a more dramatic effect thanthe simple cooling of neuronal tissue. Nerves are destroyed because thefreezing of nerve cell bodies kills the cell body. For example, U.S.Pat. No. 6,761,715 to Carroll discloses a system and method for coolingor freezing neuronal tissue in order to induce lesions and producecryoanalgesia. Additionally, U.S. Pat. No. 5,571,147 to Sluijter et al.discloses a general method of denervation of nerves to relieve back painusing both heating and cryogenic methods. While these methods may resultin an analgesic effect, the drawback of these methods is that theyresult in the destruction of nerves. The present invention does notinvolve the destruction of tissues, cell, or nerves through heating,freezing, etc to provide pain relief.

U.S. Pat. Application No. 2002/0165529 to Danek discloses a system andmethod that utilizes cryogenic energy in combination with other sourcesof energy such as ultrasound or microwave to prevent collateral damageto the surface layer because of the high temperatures used. U.S. Pat.Application No. 2003/0014098 to Quijano et al. also uses cryogenicenergy to protect peripheral tissue from applied thermal energy. Thepresent invention does not us cryogenic energy to prevent collateraldamage; the cryogenic energy used in the present invention is for anadditional therapeutic purpose for pain relief.

Therefore, there is a need for a method and device that utilize bothultrasound energy and cryogenic energy in combination to provideeffective pain relief that does not result in destruction of tissues,cells, or nerves.

SUMMARY OF THE INVENTION

The present invention is directed towards an apparatus and methods forpain relief using ultrasound waves in combination with cryogenic energy.Apparatus and methods in accordance with the present invention may meetthe above-mentioned needs and also provide additional advantages andimprovements that will be recognized by those skilled in the art uponreview of the present disclosure.

The present invention comprises an ultrasonic generator, an ultrasonictransducer, an ultrasound horn, an ultrasound tip, and a cryogenicenergy supply source. Ultrasonic waves are utilized in combination withcryogenic energy to provide more effective pain relief.

Ultrasonic energy is delivered directly to the surface area intended tobe treated for pain. Delivery can occur either through the radial sideof the sonotrode (the ultrasound horn and tip) or through the distal endof the ultrasound tip. Ultrasound energy provides a pain relief effectbecause it positively influences nerve endings, massages tissues, andstimulates cells.

Cryogenic energy is delivered in combination with ultrasound energy.Cryogenic liquid or gas (“cryogenic energy”) can be circulated throughthe delivery system, thus causing the temperate of the sonotrode todecrease. The use of cryogenic energy also provides a cooling effect onthe target either through a cooled sonotrode or through cryogenic energydelivered to the surface through an orifice on the ultrasound tip. Theuse of cryogenic energy can have two important effects. First, cryogenicenergy provides pain relief itself. This results from the recognizedtherapeutic effect of cooling a surface area with, for example, an icepack. It should be noted that, unlike other cryogenic treatment methods,the cooling effect with the cryogenic energy according to the presentinvention is not meant to freeze or destroy any tissues, cells, nerveendings, etc. The use of concurrent cryogenic pain relief can alsoincrease the effectiveness of the ultrasound pain relief effect. Second,a cooled sonotrode can prevent the temperature of the target tissue fromreaching high levels as a result of using ultrasonic energy. Whenultrasound energy is delivered to a target area, heat is generated thatraises the temperature of the target. This rise in temperature canresult in the destruction of tissues, cells, and nerve endings. Heatenergy has been used in conjunction with ultrasound to provide painrelief, but that pain relief is simply the result of the destruction ofthe nerve ending. However, the use of cryogenic energy to provide acooling effect according to the present invention prevents this increasein temperature, and therefore protects nerve endings, tissues, cells,etc from destruction.

The invention is related to the apparatus and methods of usingultrasound waves in combination with cryogenic energy to provide ananalgesic effect.

One aspect of this invention may be to provide a method and device formore effective pain relief.

Another aspect of the invention may be to provide a method and devicefor more efficient pain relief.

Another aspect of the invention may be to provide pain relief that doesnot destroy tissues, cells, or nerve endings.

These and other aspects of the invention will become more apparent fromthe written descriptions and figures below.

BRIEF DESCRIPTION OF THE DRAWINGS

The present Invention will be shown and described with reference to thedrawings of preferred embodiments and clearly understood in details.

FIG. 1 is a perspective view of an ultrasound and cryogenic pain reliefapparatus for use according to the present invention.

FIG. 2 is a cross-sectional view of an ultrasound and cryogenic painrelief apparatus.

FIG. 3 is a detailed cross-sectional view of the sonotrode section of anultrasound and cryogenic pain relief apparatus that has a rear cryogenicenergy entry port, a radial cryogenic energy exit port, and a distal endcentral orifice.

FIG. 4 is a detailed cross-sectional view of the sonotrode section of anultrasound and cryogenic pain relief apparatus that has a rear cryogenicenergy entry port, a radial cryogenic energy exit port, and no distalend central orifice.

FIG. 5 is a detailed cross-sectional view of the sonotrode section of anultrasound and cryogenic pain relief apparatus that has radial cryogenicenergy entry and exit ports, and a distal end central orifice.

FIG. 6 is a detailed cross-sectional view of the sonotrode section of anultrasound and cryogenic pain relief apparatus that has radial cryogenicenergy entry and exit ports, and no distal end central orifice.

DETAILED DESCRIPTION OF THE INVENTION

The present invention is an apparatus and methods for pain relief usingultrasound waves in combination with cryogenic energy. Preferredembodiments of the present invention in the context of an apparatus andmethods are illustrated in the figures and described in detail below.

FIG. 1 illustrates an ultrasound and cryogenic pain relief apparatusthat has an ultrasonic generator 1, a power supply cord 2, a cryogenicenergy entry port 3, an ultrasonic transducer 4, an ultrasonic horn 5, acryogenic energy exit port 6, and an ultrasonic tip 8.

FIG. 2 illustrates a cross-sectional view of an ultrasound and cryogenicpain relief apparatus shown in FIG. 1 that has an ultrasonic transducer4 that is mechanically connected to the ultrasound horn 5 by threadingor other material 11. The preferred embodiment consists of an ultrasonictransducer 4 that is mechanically connected to an ultrasound horn 5;alternative embodiments could have the ultrasonic transducer 4 directlyconnected to the ultrasound horn 5 to comprise a single piece without amechanical interface. The ultrasound horn 5 is mechanically connected tothe ultrasound tip 8 by threading or other material 7. The preferredembodiment consists of an ultrasound tip 8 that is directly connected tothe ultrasound horn 5 by a mechanical interface; alternative embodimentscould have the ultrasound tip 8 directly connected to the ultrasoundhorn 5 to comprise a single piece without a mechanical interface.Cryogenic fluid is inserted into the cryogenic energy entry port 3. Thecryogenic energy moves through the entry orifice 12 and into the airchamber 10. The cryogenic energy then goes through the exit orifice 13and out of the exit port 6 that is located on a radial side of theultrasound horn 5. A tube or other material can replace the entryorifice 12 and the exit orifice 13. This embodiment of the apparatusalso contains a central orifice 9 of ultrasound tip 8. One example of acryogenic energy to use is liquid nitrogen; other cryogenic liquids,gases, etc can also be similarly effective.

FIG. 3 is a detailed cross-sectional view of the sonotrode section ofthe ultrasound and cryogenic pain relief apparatus system shown in FIG.2 with an ultrasound horn 5 that is mechanically connected to theultrasound tip 8 by threading or other material 7. The preferredembodiment consists of an ultrasound horn 5 that is mechanicallyconnected to the ultrasound tip 8; alternative embodiments could havethe ultrasound tip 8 directly connected the ultrasound horn 5 tocomprise a single piece that does not require a mechanical interface.The ultrasound horn 5 is mechanically connected to the ultrasonictransducer (not shown) by threading or other material 11. The preferredembodiment consists of an ultrasound horn 5 that is mechanicallyconnected to the ultrasonic transducer (not shown) by threading or othermaterial 11; alternative embodiments could have the ultrasound horn 5directly connected to the ultrasonic transducer (not shown) to comprisea single piece that does not require a mechanical interface. Cryogenicfluid is inserted into the cryogenic energy entry port (not shown). Thecryogenic energy moves through the entry orifice 12 and into the airchamber 10. The cryogenic energy then moves through the exit orifice 13and out of the exit port 6 that is located on a radial side of theultrasound horn 5. A tube or other material can replace the entryorifice 12 and the exit orifice 13. This embodiment contains a centralorifice 9 of ultrasound tip 8.

FIG. 4 is a detailed cross-sectional view of the sonotrode section of anultrasound and cryogenic pain relief apparatus system that does notcontain a central orifice. The sonotrode section consists of anultrasound horn 5 that is mechanically connected to the ultrasound tip14 by threading or other material 16. The preferred embodiment consistsof an ultrasound horn 5 that is mechanically connected to the ultrasoundtip 14; alternative embodiments could have the ultrasound tip 14directly connected to the ultrasound horn 5 to comprise a single piecethat does not require a mechanical interface. The ultrasound horn 5 ismechanically connected to the ultrasonic transducer (not shown) bythreading or other material 11. The preferred embodiment consists of anultrasound horn 5 that is mechanically connected to the ultrasonictransducer (not shown) by threading or other material 11; alternativeembodiments could have the ultrasound horn 5 directly connected to theultrasonic transducer (not shown) to comprise a single piece that doesnot require a mechanical interface. Cryogenic fluid is inserted into thecryogenic energy entry port (not shown) where the cryogenic energy movesthrough the entry orifice 12 and into the air chamber 15. The cryogenicenergy then moves through the exit orifice 13 and out of the exit port 6that is located on a radial side of the ultrasound horn 5. A tube orother material can replace the entry orifice 12 and the exit orifice 13.There is no central orifice in this embodiment. The preferred embodimenthas an ultrasound tip 14 without a central orifice. An alternativeembodiment is depicted in FIG. 3 where the ultrasound tip 8 has acentral orifice 9.

FIG. 5 is a detailed cross-sectional view of the sonotrode section of anultrasound and cryogenic pain relief apparatus that has a cryogenicenergy entry port 20 on a radial side of an ultrasound horn 17—ascompared to a cryogenic entry port located on the transducer as shown inFIG. 2. The sonotrode section consists of an ultrasound horn 17 that ismechanically connected to the ultrasound transducer (not shown) bythreading or other material 26. The preferred embodiment consists of anultrasound horn 17 that is mechanically connected to the ultrasoundtransducer (not shown); alternative embodiments could have theultrasound horn 17 directly connected to the ultrasound transducer (notshown) to comprise a single piece that does not require a mechanicalinterface. The sonotrode section also consists of an ultrasound horn 17that is mechanically connected to the ultrasound tip 23 by threading orother material 22. The preferred embodiment consists of an ultrasoundhorn 17 that is mechanically connected to the ultrasound tip 23;alternative embodiments could have the ultrasound horn 17 directlyconnected to the ultrasound tip 23 to comprise one single piece thatdoes not require a mechanical interface. Cryogenic fluid is insertedinto the cryogenic energy entry port 20 that is located on a radial sideof the ultrasound horn 17. The cryogenic energy moves through the entryorifice 21 and into the air chamber 25. The cryogenic energy then movesthrough the exit orifice 19 and out of the exit port 18 that is locatedon a radial side of the ultrasound horn 17. The preferred embodimentconsists of an exit port 18 located on the direct opposite side of theultrasound horn 17 than the entry port 20 with both the exit port 18 andentry port 20 positioned at ninety-degrees to the axis of the sonotrode.Alternate embodiment could have an entry port 20 and exit port 18positioned at any other location on the ultrasound horn 17 or positionedat any other angle to the axis of the sonotrode. The entry orifice 21and the exit orifice 19 are both located off-center in the ultrasoundhorn 17. A tube or other material can replace the entry orifice 21 andthe exit orifice 19. This embodiment contains a central orifice 24 ofultrasound tip 23.

FIG. 6 is a detailed cross-sectional view of the sonotrode section of anultrasound and cryogenic pain relief apparatus that has a cryogenicenergy entry port 20 on a radial side of ultrasound horn 17. Thesonotrode section consists of an ultrasound horn 17 that is mechanicallyconnected to the ultrasound tip 28 by threading or other material 27.The preferred embodiment consists of an ultrasound horn 17 that ismechanically connected to the ultrasound tip 28; alternative embodimentscould have the ultrasound horn 17 directly connected to the ultrasoundtip 28 to comprise a single piece that does not require a mechanicalinterface. Cryogenic fluid is inserted into the cryogenic energy entryport 20 that is located on a radial side of the ultrasound horn 17. Thecryogenic energy moves through the entry orifice 21 and into the airchamber 29. The cryogenic energy then moves through the exit orifice 19and out of the exit port 18 that is located on a radial side of theultrasound horn 17. The preferred embodiment consists of an exit port 18positioned on the direct opposite side of the ultrasound horn 17 thanthe entry port 20 with both the exit port 18 and the entry port 20positioned at ninety-degrees to the axis of the sonotrode. Alternateembodiment could have an entry port 20 and exit port 18 positioned atany other location on the ultrasound horn 17 or positioned at any otherangle to the axis of the sonotrode. The entry orifice 21 and the exitorifice 19 are both located off-center in the ultrasound horn 17. A tubeor other material can replace the entry orifice 21 and the exit orifice19. This embodiment does not contain a central orifice. The preferredembodiment does not have a central orifice; alternative embodiment couldcontain a central orifice as shown in FIG. 5. The preferred embodimentof an ultrasound pain treatment apparatus does not contain a centralorifice, as depicted in FIG. 4 and FIG. 6.

The frequency range for the ultrasound waves is 15 kHz to 40 MHz, with apreferred frequency range of 20 kHz-60 kHz, and the recommendedfrequency value is 30 kHz. The amplitude of the ultrasound waves can be1 micron and above, with a preferred amplitude range of 10 microns to250 microns, and with a most preferred amplitude range of 20 microns to70 microns, and the recommended amplitude value is 50 microns. The timeof treatment and the number of treatments will vary based on a varietyof factors. These factors include the type of pain being treated(chronic, acute, phantom, etc), the source of the pain (cut, bruise,burn, etc), the periodicity of the symptoms, the duration of the pain,the reaction of the patient to the treatment, etc.

Ultrasonic waves are delivered in combination with cryogenic energy toprovide more effective pain relief. Cryogenic energy is the cryogenicmaterial such as cryogenic liquid, cryogenic gas, etc that is insertedinto the ultrasound and cryogenic pain relief apparatus. Ultrasoundwaves and cryogenic energy can be delivered either concurrently orsequentially. Ultrasound waves can be delivered either through theradial side of the sonotrode or through the distal end of the ultrasoundtip. Cryogenic energy can be delivered either through the radial side ofthe sonotrode with radial ultrasound waves, or cryogenic energy can bedelivered distally with longitudinal waves. A central orifice can beused to deliver cryogenic energy directly to the target so that thelongitudinal ultrasound waves can be delivered to the target through acryogenic spray. The preferred method of treatment is to deliver radialultrasound waves from the radial side of the sonotrode and to alsodeliver cryogenic energy from the radial side of the sonotrode.Ultrasound waves delivered alone from the radial side of the sonotrodecan also provide pain relief.

Although specific embodiments and methods of use have been illustratedand described herein, it will be appreciated by those of ordinary skillin the art that any arrangement that is calculated to achieve the samepurpose may be substituted for the specific embodiments and methodsshown. It is to be understood that the above description is intended tobe illustrative and not restrictive. Combinations of the aboveembodiments and other embodiments as well as combinations of the abovemethods of use and other methods of use will be apparent to those havingskill in the art upon review of the present disclosure. The scope of thepresent invention should be determined with reference to the appendedclaims, along with the full scope of equivalents to which such claimsare entitled.

1) A method for pain relief by using ultrasound waves in combinationwith cryogenic energy, comprising the steps of: a) delivering ultrasonicenergy to the target area; b) wherein ultrasound waves are delivered incombination with cryogenic energy; and c) wherein the ultrasound energyand cryogenic energy have an intensity capable of providing an analgesiceffect. 2) The method according to claim 1, further including the stepof generating the ultrasonic energy with particular ultrasoundparameters indicative of an intensity capable providing an analgesiceffect. 3) The method according to claim 1, further including the stepof the cryogenic source generating cryogenic energy capable of providingan analgesic effect. 4) The method according to claim 1, wherein thefrequency is in the range of 15 kHz-40 MHz. 5) The method according toclaim 1, wherein the preferred frequency is in the range of 20 kHz-60kHz. 6) The method according to claim 1, wherein the recommendedfrequency value is 30 kHz. 7) The method according to claim 1, whereinthe amplitude is at least 1 micron. 8) The method according to claim 1,wherein the preferred amplitude is in the range of 10 microns-250microns. 9) The method according to claim 1, wherein the most preferredamplitude is in the range of 20 microns-70 microns. 10) The methodaccording to claim 1, wherein the recommended amplitude value is 50microns. 11) The method according to claim 1, wherein the ultrasonicenergy and the cryogenic energy are delivered for a duration of timebased on a variety of factors such as the type of pain being treated,the source of the pain, the periodicity of the symptoms, the duration ofthe pain, the reaction of the patient, etc. 12) The method according toclaim 1, wherein the ultrasonic energy and cryogenic energy aredelivered from the radial side of the sonotrode. 13) The methodaccording to claim 1, wherein the ultrasonic energy and the cryogenicenergy are delivered through the distal end of the ultrasound tip. 14)The method according to claim 13, wherein the ultrasound energy isdelivered to the target through a cryogenic spray. 15) The methodaccording to claim 1, wherein cryogenic energy is delivered before,during, or after the delivery of the ultrasound energy. 16) An apparatusfor pain relief by using ultrasound waves in combination with cryogenicenergy, comprising: a) a generator and a transducer for generatingultrasonic energy; b) a cryogenic liquid or gas source for generatingcryogenic energy; c) wherein the ultrasound horn and/or tip deliversultrasonic waves in combination with cryogenic energy to the target; andd) wherein the ultrasound energy and cryogenic energy have an intensitycapable of providing an analgesic effect. 17) The apparatus according toclaim 16, wherein the generator and transducer generate the ultrasoundenergy with particular ultrasound parameters indicative of an intensitycapable of providing an analgesic effect. 18) The apparatus according toclaim 16, wherein the cryogenic liquid or gas source generate cryogenicenergy capable of providing an analgesic effect. 19) The apparatusaccording to claim 16, wherein the frequency is in the range of 15kHz-40 MHz. 20) The apparatus according to claim 16, wherein thepreferred frequency is in the range of 20 kHz-60 kHz. 21) The apparatusaccording to claim 16, wherein the recommended frequency value is 30kHz. 22) The apparatus according to claim 16, wherein the amplitude isat least 1 micron. 23) The apparatus according to claim 16, wherein thepreferred amplitude is in the range of 10 microns-250 microns. 24) Theapparatus according to claim 16, wherein the most preferred amplitude isin the range of 20 microns-70 microns. 25) The apparatus according toclaim 16, wherein the recommended amplitude value is 50 microns. 26) Theapparatus according to claim 16, wherein the ultrasonic energy andcryogenic energy are delivered for a duration of time by using a timerbased on a variety of factors such as the type of pain being treated,the source of the pain, the periodicity of the symptoms, the duration ofthe pain, the reaction of the patient, etc. 27) The apparatus accordingto claim 16, wherein the transducer, such as a Langevin transducer,contains a radiation surface having a surface areadimensioned/constructed for achieving delivery of the ultrasonic energyand cryogenic energy to the target with an intensity capable ofproviding an analgesic effect. 28) The apparatus according to claim 16,wherein the transducer contains a longitudinal radiation surface wherethe shape of the radiation surface is a sphere, a rectangular prism, aflat surface, a curved surface, or another comparable shape orcombination of shapes. 29) The apparatus according to claim 16, whereinthe shape of the peripheral boundary of the radiation surface iscircular, elliptical, rectangular, polygonal, or another comparableshape or combination of shapes. 30) The apparatus according to claim 16,wherein the shape of the peripheral boundary of the radiation surface isintended to achieve delivery of the ultrasonic energy and the cryogenicenergy to the target with an intensity capable of providing an analgesiceffect. 31) The apparatus according to claim 16, wherein the transduceris driven by a continuous or pulsed frequency. 32) The apparatusaccording to claim 16, wherein the transducer is driven by a fixed ormodulated frequency. 33) The apparatus according to claim 16, whereinthe driving wave form of the transducer is selected from the groupconsisting of sinusoidal, rectangular, trapezoidal and triangular waveforms.